JP2015524709A - Shock wave valve formation with multiple balloons - Google Patents

Abstract

Described herein are shock wave devices and methods for the treatment of calcified heart valves. A variation of the shock wave device includes three balloons that are sized and shaped to fit within a leaflet recess when each is inflated with liquid, and a shock wave source within each of the three balloons. Including. Each balloon can be inflated separately and / or independently, and each shock source can be controlled separately and / or independently. A method of treating a calcified heart valve using a shock wave device includes advancing the shock wave device having one or more balloons and a shock wave source in each of the balloons to contact the heart valve; Inflating one or more balloons with a liquid and activating a shock wave source may be included so that the balloon is seated in a recessed portion of the leaflet.

Description

(Citation of related application)
This application claims the benefit of US Provisional Application No. 61 / 681,068 (filed Aug. 8, 2012). The application is hereby incorporated by reference in its entirety.

  Aortic stenosis results in a narrowing of the aortic valve. Aortic stenosis can be exacerbated by a congenital defect where the aortic valve has one leaflet (single leaflet) or two leaflets (bicuspid valve) instead of three leaflets. In many cases, valve narrowing is the result of aortic valve calcification, where calcified plaque accumulates on the leaflets and / or the annulus of the aortic valve. For example, calcium plaque deposited on the leaflets of the leaflets can stiffen the leaflets, thereby narrowing the valve opening and interfering with efficient blood flow across the valve.

  While research is underway in the development of replacement aortic valves, it may be preferred to soften the leaflets by disrupting the calcium deposits on the native valve instead of replacing the prosthetic valve. Therefore, an improved method of softening the calcified aortic valve would be desirable.

  Described herein are shock wave devices and methods for the treatment of calcified heart valves. Application of shock waves to the calcified region of the valve helps to break up and / or break the calcium deposit, thereby softening and / or loosening the calcium deposit that stiffens the mechanical properties of the valve, And / or can be removed. Softening and / or loosening and / or removing the calcific deposits may allow the valve to reacquire at least a portion of its normal function. One variation of the device may comprise at least one balloon that is sized and shaped to fit into a recess in the leaflet when inflated with a liquid and a shock wave source within the balloon. Optionally, a device for treating a calcified heart valve has three balloons, three sized and shaped to fit within a leaflet recess when each is inflated with liquid A shock wave source in each of the balloons. Each balloon may be inflatable separately and / or independently, and each shock source may be separately and / or independently controllable. A shock wave device comprising three balloons and three shock wave sources can be used to treat tricuspid valves such as pulmonary and aortic valves. A shock wave device comprising one or two balloons and one or two shock wave sources can be used to treat monocuspid, bicuspid and / or tricuspid valves.

  A method of treating a calcified heart valve using a shock wave device includes advancing a shock wave device having a shock wave source within each of the one or more balloons and the balloon to contact the heart valve; Inflating one or more balloons with a liquid and activating a shock wave source so that can be placed in the recess of the leaflet. The mechanical force of the shock wave can act to crush and / or break calcific deposits located in the recesses of the leaflets. Inflation of one or more balloons with liquid may act to automatically align and / or install the balloon within the leaflet recess. The balloon and shock wave source can be inflated and activated sequentially or simultaneously for treatment of all leaflets of the valve. Once the desired level of treatment is achieved, the balloon can be deflated and withdrawn. The following description describes and depicts the treatment of the aortic valve, but similar devices and methods for treating any heart valve, eg, pulmonary valve, mitral valve, tricuspid valve, as would be desirable It should be understood that can be used.

  Other devices and methods that can be used to disrupt and / or destroy calcified deposits in the aortic valve (eg, as part of an angioplasty) are hereby incorporated by reference in their entirety. No. 2011/0295227, filed Aug. 10, 2011, U.S. Patent Application Publication No. 2013/0116714, filed Nov. 8, 2011, August 2013. This is described in US patent application Ser. No. 13 / 957,276, filed on the 1st.

  One variation of a device for the treatment of a heart valve (eg, a heart valve having a plurality of leaflets each having a recessed portion) is capable of sealing a first elongate body and a portion of the first elongate body. An encapsulating first balloon, a first shock wave source coupled to and encapsulated within the first elongate body, a second elongate body, and a portion of the second elongate body And a second shock wave source coupled to the second elongate body and enclosed within the second balloon. The first and second balloons can be independently inflatable with liquid and can be sized and shaped such that when inflated with liquid, a portion of the balloon contacts the valve. The portion of the balloon that contacts the valve may be close to the size and shape of the leaflet recess. The device optionally includes a third elongate body, a third balloon sealably enclosing a portion of the third elongate body, and a third elongate body coupled to and within the third balloon. An encapsulated third shock wave source, and the third balloon may be independently inflatable with liquid. In some variations, the shock wave sources may be movable within their respective balloons. For example, the shock sources can be rotatable about the longitudinal axis of their respective elongated bodies and / or can be advanced along the longitudinal axis of their respective elongated bodies.

  Another variation of a device for treating a heart valve (eg, a heart valve having a plurality of leaflets each having a recess) can seal a first elongate body and a portion of the first elongate body. A first balloon encapsulated in the first elongate body, a first shock wave source coupled to the first balloon and encapsulated in the first balloon, a second elongate body, and a second elongate body A second balloon sealably enclosing a portion thereof; a second shock wave source coupled to the second elongate body and encapsulated within the second balloon; a third elongate body; A third balloon sealably encapsulating a portion of the elongate body, and a third shock wave source coupled to the third elongate body and encapsulated within the third balloon. The first, second, and third balloons can be independently inflatable with liquid, and when inflated with liquid, can be sized and shaped such that a portion of the balloon contacts the valve. The portion of the balloon that contacts the valve may be close to the size and shape of the leaflet recess.

  Any of the devices described herein may further comprise at least one standoff on the outer surface of at least one of the balloons. In some variations, the at least one standoff may comprise a curved ridge along a portion of the outer surface of the balloon. Optionally, the elongate body of any of the devices described herein can comprise a compressed configuration and an expanded configuration, in which the distal portion of the elongate body can be relatively straight. In the expanded configuration, the distal portion of the elongate body can be curved.

  A method of applying a shock wave to the aortic valve is also described. One variation of the method is to introduce a shock wave device into a patient's vasculature, the shock wave device sealingly enclosing a first elongate body and a portion of the first elongate body. A balloon, a first shock wave source coupled to the first elongate body and enclosed within the first balloon, a second elongate body, and a portion of the second elongate body are hermetically sealed. And a second shock wave source coupled to the second elongate body and enclosed within the second balloon, and a first leaflet and a second valve Advancing the shock wave device within the vasculature to contact the aortic valve with the lobe and inflating the first balloon with the liquid, inflating the first balloon, Align the first balloon within the recess of the leaflet And that, by activating the first shockwave source may include a providing a shock wave to the first leaflet. The first and second balloons can be independently inflatable with a liquid. The shock wave device can be advanced in a retrograde direction within the vasculature. In some variations, the method further includes inflating the second balloon with a liquid, wherein inflating the second balloon is within the second valve leaf recess. Aligning, confirming that each of the first and second balloons is aligned within the recesses of the first and second leaflets, respectively, and first shock waves Deflating the second balloon prior to activating the source.

  Optionally, some methods are to deflate the first balloon after activating the first shock wave source and inflate the second balloon with liquid to inflate the second balloon. This may include aligning the second balloon within the recess of the second leaflet and applying a shock wave to the second leaflet by activating the second shock wave source. Alternatively or additionally, the method is to inflate the second balloon with a liquid, and inflating the second balloon aligns the second balloon within the recess of the second leaflet. Confirming that each of the first balloon and the second balloon is aligned within the recesses of the first and second leaflets, and causing the second shock wave source to Activating may include providing a shock wave to the second leaflet. In some variations, the first and second shock sources can be activated substantially simultaneously. These methods can be used to impart a shock wave to the first and second leaflets, where the first leaflet is the right half of the leaflet and the second leaflet is the late month valve. Or the first leaflet is the left half-leaflet, the second leaflet is the late-half leaflet, or the first leaflet is the right-half-leaflet, the second leaflet The leaflet is the left half-moon leaflet. The shock wave can be applied to the first and second leaflets simultaneously or sequentially. Optionally, the shock wave device used in any of these methods includes a third elongate body, a third balloon sealably encapsulating a portion of the third elongate body, A third shock wave source coupled to the elongate body and encapsulated within the third balloon, the third balloon being independently inflatable with a liquid.

  Another variation of the method of applying a shock wave to the aortic valve is to introduce a shock wave device into the patient's vasculature, which can seal the first elongate body and a portion of the first elongate body. A first balloon encapsulated in the first elongate body and a first shock wave source coupled to the first elongate body and encapsulated in the first balloon; Advancing the shock wave device within the vasculature to contact an aortic valve having two leaflets and inflating the first balloon with liquid, inflating the first balloon; Aligning the first balloon within the recess of only the first leaflet, and applying a shock wave to the first leaflet by activating the first shockwave source, Treating. The first and second balloons can be independently inflatable with a liquid. The shock wave device can be advanced in a retrograde direction within the vasculature. The method further includes deflating the first balloon after the first leaflet has been treated, moving the first balloon to the second leaflet, and inflating the first balloon with the liquid. That is, inflating the first balloon aligns the first balloon within the recess of only the second leaflet, and activates the first shock wave source to cause the first shock wave to be generated. Treating the second leaflet by providing to the second leaflet. In some variations, the shock wave device is further coupled to the second elongate body, a second balloon sealably enclosing a portion of the second elongate body, the second elongate body, And a second shock wave source enclosed in the two balloons. The second balloon may be inflatable with a liquid independent of the first balloon. A method of using a shock wave device comprising two balloons optionally includes deflating the first balloon and inflating the second balloon with liquid after treating the first leaflet. And inflating the second balloon aligns the second balloon within the recess of the second leaflet only, and activates the second shock wave source to cause the second shock wave to Treating the second leaflet by providing to the leaflet. Optionally, the shock wave device used in any of the methods described herein further includes a balloon when the at least one balloon is inflated with a liquid and positioned with a recess in the leaflet. There may be at least one standoff on the outer surface of at least one of the balloons so that does not interfere with blood flow to the coronary artery.

FIG. 1A depicts a cutaway view of the heart taken along the plane shown in the inset. FIG. 1B depicts a top view of the heart as viewed from the base with the atrium removed. FIG. 1C is an illustration of an aortic valve that has been cut forward and expanded between the left and right leaflets. FIG. 1D is a top view of a calcified aortic valve. FIG. 1E is a top view of a bicuspid aortic valve. FIG. 2A schematically depicts a variation of a shock wave device for the treatment of calcified heart valves. FIG. 2B depicts the distal portion of the shock wave device of FIG. 2A. FIG. 2C depicts a proximal view of the distal portion of FIG. 2B. FIG. 2D is a side view of the distal portion of FIG. 2B. FIG. 2E is a top view of the device of FIGS. 2A-2D deployed in the leaflets of the aortic valve. FIG. 2F is a side view of the device of FIGS. 2A-2D deployed in the leaflets of the aortic valve. FIG. 3 schematically depicts a variation of a shock wave device for treatment of a calcified heart valve comprising three balloons and three shock wave sources within the balloon. 4A-4C depict a variation of a method for treating a calcified heart valve using a shock wave device. 4A-4C depict a variation of a method for treating a calcified heart valve using a shock wave device. 4A-4C depict a variation of a method for treating a calcified heart valve using a shock wave device. FIG. 4D depicts a schematic top view of a shock wave device deployed in an aortic valve. 5A-5C are flowchart representations of additional variations of a method of treating a calcified heart valve using a shock wave device. 5A-5C are flowchart representations of additional variations of a method of treating a calcified heart valve using a shock wave device. 5A-5C are flowchart representations of additional variations of a method of treating a calcified heart valve using a shock wave device.

  1A-1C depict various views of a heart valve. FIG. 1A is a cut-away view of the heart 100 taken along the plane indicated by the inset. The aortic valve 101 includes a left meniscus or leaflet 102, a right meniscus or leaflet 104, and a half moon leaflet or leaf 106. Each leaflet has a free edge that articulates with the free edge of the other leaflet when the valve is closed, and an attachment edge that attaches the leaflet to the aortic wall in a semi-moon shape. When the aortic valve is closed, the ventricular side of the leaflets can have a convex surface and the aortic side of the leaflets can have a concave surface. Each concave portion of the leaflet may be bounded by a concave surface of the leaflet, a free edge of the leaflet, a leaflet attachment edge, and may include a portion of the valve wall. Alternatively or in addition, each recess portion of the leaflets may include an aortic sinus associated with each leaflet. FIG. 1B shows the upper surface of the aortic valve 101 (viewed from the base from which the atrium has been removed) in a closed configuration, showing the recesses of each of the left meniscus leaflet 102, right meniscus leaflet 104, and late meniscus leaflet 106. Depict the figure. As shown there, the free edges 108 of the leaflets articulate with each other to prevent blood from passing through the valve when closed. The left, right, and posterior leaflet recesses 110, 112, 114 are also shown in FIG. 1B. As depicted in FIG. 1C, the concave portion of each leaflet may also include a portion of the aortic sinus 111, 113, 115 associated with that leaflet. The recessed portion 110 or aortic sinus 111 of the left leaflet 102 may include an opening 116 to the left coronary artery 118, and the recessed portion 112 or the aortic sinus 113 of the right leaflet 104 may include an opening 120 to the right coronary artery 122. Can be provided. The posterior leaflet recess 114 or aortic sinus 115 may not have any coronary opening.

  1D and 1E depict an aortic valve that may be susceptible to stenosis. As shown in FIG. 1D, calcified plaques or deposits may accumulate on the aortic side of the leaflets, for example, along the concave portion of the leaflets, as shown by the dashed line regions 130,132. Calcium deposits on the aortic leaflets and walls can significantly stiffen the valve and impair its ability to open and close effectively. Nodular deposits 132 can accumulate along the free edge of the leaflets, and a layer 130 of deposits can accumulate within the recesses of the leaflets (eg, along the aortic side of the leaflets). The nodular deposit 132 may act to attach the free edges of the leaflets to each other, which will reduce the size of the valve opening. Layered deposits along the aortic surface of the leaflets (eg, the depression and / or the aortic sinus) can act to stiffen the leaflets and interfere with their ability to open and close. Some patients may have a bicuspid aortic valve, a congenital condition that can result in an aortic valve having two leaflets instead of three. FIG. 1E depicts a bicuspid aortic valve whose function can be particularly impaired by the accumulation of calcified deposits along the free edges and / or recesses of the two leaflets. Breaking, destroying, and / or removing these deposits can help the aortic valve reacquire its normal function. The shock wave devices and methods described herein provide for aortic leaflets to disrupt, destroy, soften, remove, and / or otherwise reduce the effects of calcific deposits on valve function. And / or can be delivered to a recess in the aortic sinus.

  A shock wave device that can be used to treat a calcified region of an aortic valve includes an elongated body, a balloon that sealably encloses a portion of the elongated body, and a shock wave source coupled to and enclosed within the elongated body. Can be provided. The balloon can be filled with liquid, and when the shock wave source is activated, the shock wave can propagate through the liquid and impart mechanical force to the wall of the balloon. By placing the balloon wall in contact with a calcified tissue region (eg, a leaflet recess and / or aortic sinus), mechanical force from the shock wave can be transferred to the calcific deposit, thereby depositing the deposit. Crush and / or break. The closer to contact between the balloon wall and the calcified tissue, the more efficient is the transfer of mechanical energy from the shock wave device to the calcific deposit. Furthermore, the closer the shock wave source in the balloon is to calcified tissue, the greater the magnitude of mechanical force that can be delivered to the calcific deposit. The size and shape of the balloon is such that when the balloon is inflated with liquid, at least a portion of the balloon can be placed and / or positioned within the leaflet recess and / or the aortic sinus. Can be selected. For example, the balloon may be sized and positioned so that the balloon is inflated proximate the aortic leaflet, and the balloon automatically installs and / or positions itself within the leaflet recess and / or the aortic sinus. Can be molded. The balloon size and shape can be tailored to the unique geometry of the patient's aortic valve (eg, to match the aortic leaflet and / or aortic sinus geometry). For example, the diameter of the balloon can be from about 5 mm to about 15 mm, which can correspond to the size of the leaflet recess. The balloon may be spherical, but may also have other shapes that may help to position it in the recessed portion of the valve (eg, with rounded and / or sharp corners or edges 4 Facets, rounded and / or cones with sharp corners or edges, squares, circles, triangle blocks, etc.). The balloon can be made of a non-flexible material and can be shaped to mimic the shape of the coronary sinus of the valve.

  Optionally, the elongate body of the shock wave device is advanced through the vasculature in a relatively linear configuration (eg, constrained by a guide tube) and, when deployed, prior to or during inflation. It may have shape memory so that it can take a curvilinear or bent configuration that may help to place the balloon in (or close to) the aortic surface of the lobe. For example, the elongate body takes a bent and / or expanded configuration that, when deployed in or near the leaflets, can help the device self-align the balloon within the leaflet recess and / or the aortic sinus. Can be energized as follows. The balloon can be coupled to a distal portion of the elongated body that can provide a fluid pathway to fill the balloon with saline or a saline / contrast medium mixture. The elongate body can be formed of a flexible material to absorb volume changes that can be caused by vapor bubbles, which can result from shock waves generated in the balloon. In some variations, the shock wave source enclosed within the balloon is movable within the balloon so that the shock wave can be initiated from anywhere within the balloon to impart mechanical force to the target area of the tissue. It can be. For example, the shock source may be advanced or retracted longitudinally (eg, about the axis of the elongated body) along the axis of the elongated body (eg, from proximal to distal direction) and / or rotated Or can be bent at an angle with respect to the axis of the elongated body (eg, the distal tip of a steerable catheter and / or catheter with shape memory so that the shock source assumes a bent configuration when unconstrained Can be located).

  Optionally, the balloon of the shock wave device may comprise one or more standoff structures on its outer surface. Examples of standoff structures may include but are not limited to ridges, bumps, protrusions, posts, and the like. These standoff structures may help to avoid inflating balloons that are placed in the leaflet recesses and / or the aortic sinus to block any arterial openings that may be in the aortic sinus. For example, having one or more standoff structures on a balloon that is inflated in the left or right leaflet prevents the balloon from blocking the left or right coronary artery opening. Can help. Maintaining the patency of the coronary artery opening may allow continuous perfusion to the heart while the shock wave procedure is being performed, which may help reduce the occurrence of cardiac ischemia during the procedure .

  A shock wave device comprising a single elongate body, a balloon, and a shock wave source can be used to treat one leaflet of the valve at a time (ie, simultaneously, the first leaflet of the first leaflet). After treatment, the device can be repositioned and placed in the recess of the second leaflet to treat the second leaflet, etc.). In some variations, the shock wave device may comprise two or three sets of elongated bodies, a balloon, and a shock wave source that may allow treatment of multiple leaflets and bicuspid aortic valve. Additional balloons may also help to install and / or position the shock wave device within the leaflet recess more efficiently and / or precisely. Although certain features and structures are described with respect to particular variations of the shock wave device, it should be understood that these features and structures may also be incorporated into other variations of the shock wave device.

  One variation of a shock wave device that can be used to fracture and / or break calcified deposits located in an aortic valve is depicted in 2A-2D. The shock wave device 200 may comprise an elongate body 202, a balloon 204 that sealably encloses a portion of the elongate body, and a shock wave source 206 within the balloon. Balloon 204 may be located at the distal end of elongate body 202 and fluid (eg, liquid at the proximal end of the elongate body (eg, via port 210, which may be a luer lock connector of proximal handle portion 211). ) May be inflatable. Alternatively, the elongate body can have a separate fluid lumen for inflating the balloon. The balloon 204 has two elongated protrusions or ridges 212a along its outer surface that can serve as a standoff to prevent occlusion of the coronary artery opening when the balloon is inflated in the leaflet. 212b. The shock wave source 206 can comprise a shaft 208 connected to a high voltage power supply and at least one electrode pair 207 located at the distal end of the shaft. The shock wave source 206 is moved along the longitudinal axis of the elongate body 202 (e.g., in the elongate body 202 according to the arrow 201) by turning and / or pushing and / or pulling the knob 213 of the proximal handle portion 211. And can be advanced and / or rotated about the longitudinal axis of the elongate body 202 (eg, bent according to arrow 203 and / or at an angle). The shaft 208 can be a steerable shaft, where an actuation mechanism (eg, a pull wire) can be used to bend the shaft, and / or pre-aligned so that the shaft has a bend 205 when in an unconstrained configuration. It may have a shape memory that is molded. The shock wave source 206 depicted in the drawings comprises an electrode pair 207 in a coaxial configuration at the distal end of the shaft 208, although there can be more than one electrode pair along the shaft, and there are various electrode pairs. It should be understood that the configuration can be In some variations, the shock wave electrode pair may be located along the side of the shaft 208. Examples of shock wave electrode configurations are disclosed in US Application Publication No. 2009/0312768, filed June 11, 2009, and March 14, 2013, both of which are incorporated herein by reference in their entirety. This is described in US application Ser. No. 13 / 831,543, filed daily. Alternatively or additionally, the shock wave source may comprise an optical fiber or a laser configured to generate the shock wave.

  2C and 2D depict top and side views of balloon 204, ridges 212a and 212b, and shock source 206. FIG. 2E depicts a top view of the shock wave device deployed in the aortic valve 230 and FIG. 2F depicts a side view (only the left valve leaf 232 of the valve is depicted). As can be seen from the side view of FIG. 2F, the balloon 204 is filled with liquid and placed in the recessed portion 234 of the left leaflet 232. The inflation of the balloon 204 and / or the shape memory of the elongated body 202 can help the balloon 204 self-align into the recessed portion 234 of the left leaflet 232. The balloon is within the leaflet recess 234 such that the balloon is bounded by the valve wall 240 (eg, aortic sinus wall), the leaflet (aortic side) concave surface 242 and the leaflet free edge 244. Can be installed on. When installed in a concave portion of a leaflet, the balloon crosses the free edge of the leaflet and does not intersect the free edge of another leaflet (eg, the balloon does not cross two leaflets, and / or The balloon can be pressed against the valve wall 240 so that the balloon does not extend into the aortic valve orifice. As can be seen from the top view of FIG. 2E, the balloon is seated in the recessed portion 234 such that it is bounded by the valve wall 240 and the free edge 244 of the leaflet. The balloon may also include ridges 212a, 212b that help ensure that the balloon does not occlude the left coronary opening 236. Although two ridges are depicted, it should be understood that there can be any number of ridges or protrusions, as may be desirable to ensure that there is a space between the balloon wall and the aortic wall. (For example, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, etc. protrusions or bumps).

  A shock wave device for treatment of calcified heart valves may comprise an additional set of elongated bodies, balloons, and shock wave devices. Some variations include two elongate bodies, two balloons (each encapsulating a portion of the two elongate bodies), and two shock wave sources (one in each of the two balloons). Can have. Other variations may have three sets of elongated bodies, a balloon, and a shock wave device, such as the shock wave device 300 depicted in FIG. The shock wave device 300 includes a first elongate body 302, a first balloon 304 that sealably encloses a portion of the first elongate body, a first shock wave source 306, a second elongate body 312 and a second elongate body 312; A second balloon 314 that sealably encloses a portion of the two elongate bodies, and a second shock wave source 316, a third elongate body 322, and a portion of the third elongate body that are sealably encapsulated. A third balloon 324 and a third shock wave source 326 may be provided. The shock source can be connected to the high voltage pulse generator 301 at the proximal end, the positive terminal of each shock source can be connected to the positive port of the pulse generator, and the negative terminal of each shock source can be a common ground terminal Can be connected to. The first, second, and third balloons can be inflatable separately and / or independently (eg, having separate inflation lumens). In some variations, the first, second, and third balloons may be inflated one at a time (eg, continuously) and / or two at a time. All balloons of the shock wave device can also be inflated simultaneously. For example, as depicted in FIG. 3, the three elongate bodies 302, 312, 322 connect to the common shaft 303 and share the common inflation lumen 341 of the proximal handle 340. The first, second, and third shock sources can be activated separately and / or independently. Each of the shock wave sources 306, 316, 326 includes an insulating shaft 307, 317, 327 that can house the wiring between the high voltage pulse generator and the shock wave electrodes 305, 315, 325 at the distal end of the shaft. obtain. The pulse generator is programmed to provide voltage pulses to each of the shock sources either sequentially (eg, one at a time) or simultaneously (eg, two at a time, three at a time). Can be controlled by a controller. Each of the three balloons and corresponding shock wave sources can be inflated, actuated, and activated by three separate proximal handle portions, each similar to the handle portion described and depicted in FIG. 2A. If desired, an actuating mechanism for moving additional fluid ports and / or shock sources can be included in the proximal portion.

  Insulating shafts 307, 317, 327, and / or elongate bodies 302, 312, 322 can be biased to expand when unconstrained (eg, by an overtube or catheter). In some variations, the shaft and / or elongate body may be spring biased and / or have shape memory to assume a bent and / or expanded configuration when unconstrained. . The expansion and / or bending of the shaft and / or elongate body allows the balloon to self-align with the leaflets when the balloon is inflated and is installed within the leaflet recess and / or the leaflet aorta. Can be used to position the balloon along the aortic valve so that it can be and / or positioned.

  4A-4C depict one variation of a method for treating a calcified heart valve (eg, an aortic valve) using a shock wave device. The method depicted therein uses a shock wave device comprising two balloons, but this method uses any of the shock wave devices disclosed herein (eg, one balloon or three balloons). It should be understood that this can be done using a shock wave device. FIG. 4A depicts a cross-sectional schematic view of the aortic valve 400 with the left and right leaflets 402 and 404 (the posterior leaflets are not shown for simplicity). The recessed portion 403 of the left leaflet 402 includes a left aortic sinus and an opening 407 of the left coronary artery 406. The recessed portion 405 of the right leaflet 404 includes the right aortic sinus and the opening 409 of the right coronary artery 408. A guide catheter 410 can be introduced into the vasculature and advanced to the aortic valve 400 in a retrograde direction (eg, via the femoral artery). Guide catheter 410 (as well as any of the components of the shock wave device) may include a radiopaque band or marker so that the location of the catheter can be determined using fluoroscopy. Alternatively or in addition, the location of the catheter and / or any shock wave device can be determined using ultrasound. The guide catheter 410 may be positioned immediately downstream (eg, upward) from the leaflets. The shock wave device 412 can then be advanced through the guide catheter 410 to the aortic valve. The shock wave device 412 includes a first elongate body 414, a first balloon 416 sealably attached to the distal end of the first elongate body 414, and a first encapsulated within the first balloon 416. A shock wave source 418, a second elongate body 424, a second balloon 426 sealably attached to the distal end of the second elongate body 424, and a second encapsulated within the second balloon 426. A shock wave source 428. Alternatively, the shock wave device can be any of the shock wave devices described herein. The first and second elongate bodies and / or the shafts of the first and second shock sources can be biased to bend and / or expand at an angle when unconstrained. The shock wave device 412 is advanced through the guide catheter 410 in a compressed configuration where the first and second elongated bodies and / or the shafts of the first and second shock wave sources can be generally aligned with the longitudinal axis of the guide catheter 410. Can be made.

  As shown in FIG. 4B, the first and second elongate bodies and / or the first and second shock source shafts are advanced by advancing the shock wave device 412 distally beyond the distal end of the guide catheter. Can take their bent configuration, thereby expanding the shock wave device so that the first and second balloons 416, 426 (which are deflated during delivery) contact the aortic valve wall. obtain. Expansion of the shock wave device can help to align the balloon at least partially with the left and right leaflet recesses 403, 405, away from the valve orifice, and to position the balloon along the valve wall. Next, as depicted in FIG. 4C, one or both of the balloons can be inflated with liquid, which can self-align the balloon within the leaflet recesses, and the leaflet recesses and / or Or it may serve to reduce the amount of manipulation of the shock wave device needed to position the balloon within the aortic sinus. In some variations, only one balloon can be inflated at a time, or two balloons can be inflated simultaneously. Inflating a balloon that has fewer than the number of leaflets of the valve may allow blood to flow through at least a portion of the valve, which may help reduce the risk of developing ischemia during the procedure. .

  The balloon may act to maintain a space between the inflated balloon and the valve wall (eg, so that the inflated balloon does not block the arterial openings 407, 409). (Not shown in FIGS. 4A and 4B, but shown in FIG. 4C). This may allow continuous perfusion around the leaflets through the valve and blood flow into the left and right coronary arteries 406, 408 through the arterial openings 407, 409. FIG. 4D shows a top view of a shock wave device comprising three balloons 433, 434, 435 (inflated with fluid) enclosing three shock wave sources 436, 437, 438 that can be deployed in the aortic valve 440. Depict. Each balloon may comprise at least two ridges 430 that serve to maintain a space between the balloon and the valve wall, which may serve to prevent obstruction of the opening to the coronary arteries 432,434. As can be seen, each of the three balloons is seated within the respective recess and / or aortic sinus 441, 442, 443 of the aortic valve leaflet. The location of the balloon can be determined based on fluoroscopy and / or ultrasound as previously indicated. For example, a portion of the ridges 417, 427 can be made of a radiopaque material that can be visualized using fluoroscopy. Radiopaque ridges ensure that the practitioner confirms that the balloon is seated in the leaflet recess and / or the aortic sinus, and that the bulge itself does not occlude the opening to the coronary artery And / or confirming that the balloon has not been inserted through the valve opening and / or has not blocked the valve opening. In some variations, the biasing of the elongated body and / or the shock wave shaft may cause the balloon to self-align with the valve leaflets as the balloon is inflated and / or automatically Can be helpful to install in. Such biasing also ensures that none of the balloons occlude and / or extend through the valve mouth, but instead are squeezed along the valve wall. Can be helpful for.

  After the practitioner confirms that the balloon is in the desired position, one or more of the shock wave sources can be activated to generate the shock wave. The location of the balloon and / or shock wave device may be monitored throughout the treatment procedure as needed to ensure that the balloon is in close proximity and / or contact with the calcified region of the valve. Mechanical force from the shock wave can propagate through the liquid to impart mechanical force to the calcified deposit along the leaflet surface. Multiple shock waves can be applied to the leaflets and / or valve structure. In some variations, the shock wave device can be moved within the balloon so that the mechanical force from the shock wave can be focused on different regions of the leaflets without moving the balloon. For example, shock wave treatment of a calcified leaflet starts with a shock wave from a shock wave source at a first location (e.g., mechanical force can be applied to the calcified deposit along the leaflet attachment edge), and then Moving the shock wave source in the balloon to a second location, and then the shock wave from the shock wave source at the second location (eg, mechanical force can be applied to the calcified deposit along the free edge of the leaflet). Starting. The effectiveness of the treatment can later be assessed based on imaging techniques (eg, fluoroscopy and / or ultrasound) and / or physiological parameters. An example of a technique that can be used to assess the effectiveness of treatment is an ultrasound visual representation of leaflet activity (eg, leaflet opening and closing) when the balloon is deflated or withdrawn from the valve. Measurements such as observation, ejection fraction, Duke activity status index (DASI), peak velocity, peak slope, valve effective mouth area, Doppler velocity, etc. may be included, but are not limited thereto.

  Optionally, a transcatheter aortic valve implantation (TAVI) procedure can be performed after the desired amount of calcium deposits has been crushed and / or loosened and / or after the leaflets have been softened. Breaking and / or breaking the calcific deposits on the aortic valve can help to improve the outcome of subsequent TAVI procedures. In the following, additional methods are described that may include one or more of the steps described above.

  In some methods, a single leaflet of the valve can be treated at a time, while in other methods, two or more leaflets of the valve can be treated simultaneously. FIGS. 5A-5C depict a flowchart diagram representing a variation of the method of disrupting and / or destroying calcified deposits that may be located along the surface of the aortic leaflets. In one variation, as depicted in FIG. 5A, sequentially, a first calcified leaflet (eg, right leaflet), then a second calcified leaflet (eg, left leaflet), then A shock wave device with a single balloon and a shock wave source within the balloon can be used to treat a calcified third leaflet (eg, posterior leaflet). In this method 500, the guide catheter is advanced in a retrograde direction to the aortic valve (502), and the shock wave device is advanced through the guide catheter as previously described (504). A balloon is deployed to the first leaflet (506), it is inflated with fluid (508), and the lobe recess and / or its location within the aortic sinus is identified (510). A shock wave source in the balloon can be activated 512 and mechanical forces from the plurality of shock waves can act to break and / or break the calcium deposits in the first leaflet. Once the first leaflet has been satisfactorily treated, the shock wave device is moved (eg, rotated) so that the balloon is moved from the first leaflet to the recessed portion of the second leaflet (step 514). The balloon may or may not be deflated prior to moving it to the second leaflet. After the location of the balloon in the recess of the second leaflet is identified, the shock wave source in the balloon can be activated (516). The process can then be repeated for the third leaflet (steps 518-520).

  In another variation, as shown in FIG. 5B, a shock wave device with two balloons and two shock wave sources may be used to sequentially treat one calcified leaflet at a time. In such a method 530, the shock wave device is advanced to the aortic valve as previously described (steps 532, 534), and then both balloons are deployed (536), causing the balloons to become concave portions of the leaflets. It can be inflated at the same time to install in (538). Optionally, a shock wave device with three balloons and three shock wave sources can inflate all three balloons simultaneously. Once the balloon position is confirmed (step 540, eg, the balloon is aligned with and / or located within the leaflet recess), the first balloon in the first leaflet Can be deflated, while the second balloon in the second leaflet can remain inflated (542). If a three-balloon shock wave device is used, the third balloon in the third leaflet can be deflated. A shock wave source in the second balloon may be activated (544) to disrupt and / or destroy calcified deposits in the second leaflet. Inflating more than one balloon may help to position and / or install the balloon within the leaflet recess. Contracting all but one of the balloons during treatment helps to reduce blockage of blood flow through the valve during the procedure, and thus can extend the time available to perform the entire procedure. After the second leaflet has been treated, the second balloon can be deflated and the first balloon can be inflated to treat the first leaflet (546). A shock wave source in the first balloon may be activated (548) to crush and / or break calcified deposits in the first leaflet. If desired, these steps can be repeated (eg, for treatment of the third leaflet and / or for treatment of the first and second leaflets).

  FIG. 5C depicts an example of a method 550 for treating two (or three) calcified leaflets simultaneously. A shock wave device comprising two balloons and two corresponding shock wave sources can be advanced to the aortic valve as previously described (steps 552, 554). In some variations, instead of a two-balloon shock wave device, a three-balloon shock wave device. Two balloons can be deployed (556) and inflated at the same time (558) to place the balloon in the recessed portion of the leaflet (558) (Using a three-balloon device, the third balloon is optionally inflated. obtain). Once it is determined that the position of the balloon within the leaflet recess is in a given contact with the calcified deposit (560), mechanical force is applied to the calcified deposit in both leaflets. As such, the two shock sources in the two balloons may be activated simultaneously (562). After the two leaflets have been treated, at least one of the balloons can be deflated (564). The third leaflet (eg, in the case of a two-balloon shock wave system) rotates the shock wave device so that the balloon is aligned with the third leaflet and / or is seated within the third leaflet. Inflating the balloon within the third leaflet (566), ascertaining its location within the third leaflet (568), and shock waves within the balloon to treat the third leaflet Can be treated by activating the source (570). If a three-balloon shock wave device is used, the device does not need to be repositioned to treat the third leaflet; instead, the third balloon is installed in the third leaflet. It can be inflated (566) and a third shock source can be activated (570). Confirming the position of the third balloon within the third leaflet may be optional. Optionally, when the third balloon is inflated, one or both of the other two balloons can be deflated. In some variations, three balloons can be inflated simultaneously to treat three leaflets simultaneously. If a three-balloon system is capable of inflating more than one balloon to treat more than one leaflet at a time, in some variations, a single single at a time Three balloon systems can be used to treat the leaflets (ie, inflate only one balloon at a time). Continuous inflation of a single balloon at a time may be desirable if the practitioner desires to reduce the level of occlusion of the aortic valve during treatment.

  In a method in which two calcified leaflets are treated simultaneously, one of the leaflets may have a coronary artery opening in its sinus (eg, right or left leaflet) while the other leaflet is May not have a coronary opening in its sinus (eg, posterior leaflet). By leaving the third leaflet (eg, the left or right leaflet) unoccluded by the balloon while the other two leaflets are being treated, the coronary artery associated with that leaflet It can help to ensure consistent blood flow to and to keep part of the valve opening open during treatment. For example, a balloon can be inflated in these leaflets to treat the left and posterior (non-coronary) leaflets, while being aligned within the concave portion of the right leaflet, and The / or positioned balloon may remain deflated. After the left leaflet has been treated, its corresponding balloon can be deflated and the balloon in the right leaflet can be inflated. The shock wave source in the balloon in the right leaflet can then be activated to treat the right leaflet. Optionally, the balloon in the posterior leaflet can remain inflated for continuous treatment (eg, simultaneously with treatment of the right leaflet), or the balloon can be deflated. These steps can be repeated as desired. In other variations, the right and left leaflets can be treated simultaneously, and the balloons placed in these leaflets can be inflated simultaneously. As previously described, the balloon can be used to maintain a space between the balloon and the wall of the coronary sinus where the coronary opening is located (e.g., one or more standoff structures (e.g., Ridges, etc.). Maintaining this space may allow blood to continue to flow into the coronary artery and reduce the degree to which the inflated balloon occludes the coronary opening. After the left and right leaflets have been treated, one or both of the balloons in the right and left leaflets can be deflated and the balloon in the posterior leaflets can be inflated. In yet another variation, a balloon can be placed and inflated in the three leaflets of the aortic valve so that the three leaflets can be treated simultaneously.

  The methods and devices described above can also be used to treat bicuspid aortic valves. For example, a method of treating a calcified bicuspid aortic valve may include inflating only one balloon of the shock wave device to treat only one leaflet at a time. In other variations, a method of treating a calcified bicuspid aortic valve may include inflating two balloons at a time for simultaneous shock wave treatment of both leaflets. Optionally, a TAVI procedure can be performed after treating the valve with a shock wave device.

  While the invention has been particularly shown and described with reference to embodiments thereof, those skilled in the art will recognize that various changes in form and detail may be made thereto without departing from the scope of the invention. Will be understood. For all of the embodiments described above, the method steps need not be performed continuously.

Claims (23)

A device for the treatment of a heart valve, wherein the heart valve has a plurality of leaflets each having a recess;
The device is
A first elongated body;
A first balloon sealingly enclosing a portion of the first elongated body;
A first shock wave source coupled to the first elongated body and encapsulated within the first balloon;
A second elongated body;
A second balloon sealably enclosing a portion of the second elongated body;
A second shock wave source coupled to the second elongated body and enclosed within the second balloon;
The first and second balloons are independently inflatable with a liquid, and when inflated with the liquid, a portion of the balloon is sized and shaped to contact the valve; The device wherein the portion of the balloon in contact with the valve is close in size and shape to the indentation of the leaflet.   A third elongate body, a third balloon sealingly enclosing a portion of the third elongate body, and being coupled to the third elongate body and enclosed within the third balloon. The device of claim 1, further comprising a third shock wave source, wherein the third balloon is independently inflatable with a liquid.   3. A device according to claim 1 or claim 2, wherein the shock wave sources are movable within their respective balloons.   The device of claim 3, wherein the shock wave sources are rotatable about the longitudinal axis of their respective elongated bodies.   5. The device of claim 3 or claim 4, wherein the shock wave sources are advanceable along the longitudinal axis of their respective elongated bodies. A device for the treatment of a heart valve, wherein the heart valve has a plurality of leaflets each having a recess;
The device is
A first elongated body;
A first balloon sealingly enclosing a portion of the first elongated body;
A first shock wave source coupled to the first elongated body and encapsulated within the first balloon;
A second elongated body;
A second balloon sealably enclosing a portion of the second elongated body;
A second shock wave source coupled to the second elongate body and enclosed within the second balloon;
A third elongated body;
A third balloon sealingly enclosing a portion of the third elongated body;
A third shock wave source coupled to the third elongated body and encapsulated within the third balloon;
With
The first, second, and third balloons are independently inflatable with a liquid, and when inflated with the liquid, are sized and shaped such that a portion of the balloon contacts the valve. And the portion of the balloon in contact with the valve is close in size and shape to a leaflet recess.   The device according to any one of the preceding claims, further comprising at least one standoff on an outer surface of at least one of the balloons.   The device of claim 7, wherein the at least one standoff comprises a curved ridge along a portion of the outer surface of the balloon.   The elongate body comprises a compression configuration and an expanded configuration, wherein in the compressed configuration, a distal portion of the elongate body is relatively straight, and in the expanded configuration, the distal portion of the elongate body is The device according to claim 1, wherein the device is curved. A method of applying a shock wave to an aortic valve,
Introducing a shock wave device into a patient's vasculature, the shock wave device including a first elongate body, a first balloon sealably enclosing a portion of the first elongate body, and A first shock wave source coupled to a first elongate body and enclosed within the first balloon, a second elongate body, and a portion of the second elongate body are hermetically sealed. A second balloon and a second shock wave source coupled to the second elongated body and enclosed within the second balloon, wherein the first and second balloons are independently liquid Inflatable, and
Advancing the shock wave device within the vasculature to contact an aortic valve having a first leaflet and a second leaflet;
Inflating the first balloon with a liquid, inflating the first balloon, aligning the first balloon within a recess of the first leaflet;
Applying a shock wave to the first leaflet by activating the first shock wave source. Inflating the second balloon with a liquid, inflating the second balloon, aligning the second balloon within a recess of the second leaflet; and
Verifying that each of the first balloon and the second balloon are aligned within the recesses of the first and second leaflets, respectively.
11. The method of claim 10, further comprising: deflating the second balloon prior to activating the first shock wave source. Deflating the first balloon after activating the first shock wave source;
Inflating the second balloon with a liquid, inflating the second balloon, aligning the second balloon within a recess of the second leaflet; and
The method according to claim 10 or 11, further comprising: applying a shock wave to the second leaflet by activating the second shock wave source. Inflating the second balloon with a liquid, inflating the second balloon, aligning the second balloon within a recess of the second leaflet; and
Verifying that each of the first balloon and the second balloon are aligned within the recesses of the first and second leaflets, respectively.
The method of claim 10, further comprising: providing a shock wave to the second leaflet by activating the second shock wave source.   The method of claim 13, wherein the first and second shock sources are activated substantially simultaneously.   15. The method according to any one of claims 10 to 14, wherein the first leaflet is a right half-leaflet and the second leaflet is a late-half leaflet.   15. The method according to any one of claims 10 to 14, wherein the first leaflet is a left half-leaflet and the second leaflet is a late-half leaflet.   15. The method according to any one of claims 10 to 14, wherein the first leaflet is a right meniscus leaflet and the second leaflet is a left meniscus leaflet.   The shock wave device is coupled to the third elongate body, a third balloon sealingly enclosing a portion of the third elongate body, and the third elongate body, The method of claim 10, further comprising a third shock wave source encapsulated in the first balloon, wherein the third balloon is independently inflatable with a liquid. A method of applying a shock wave to an aortic valve,
Introducing a shock wave device into a patient's vasculature, the shock wave device including a first elongate body, a first balloon sealably enclosing a portion of the first elongate body, and A first shock wave source coupled to a first elongate body and enclosed within the first balloon, wherein the first balloon is inflatable with a liquid;
Advancing the shock wave device within the vasculature to contact an aortic valve having a first leaflet and a second leaflet;
Inflating the first balloon with a liquid, inflating the first balloon, aligning the first balloon within a recess of only the first leaflet; and
Treating the first leaflet by applying a shock wave to the first leaflet by activating the first shockwave source. Deflating the first balloon after treating the first leaflet;
Moving the first balloon to the second leaflet;
Inflating the first balloon with a liquid, the inflating the first balloon aligning the first balloon within a recess of only the second leaflet; and
20. The method of claim 19, further comprising: treating the second leaflet by applying a shock wave to the second leaflet by activating the first shock wave source. The shock wave device is coupled to the second elongate body, a second balloon sealingly enclosing a portion of the second elongate body, and the second elongate body, A second shock wave source enclosed in the first balloon, wherein the second balloon is inflatable with a liquid independently of the first balloon, and the method comprises:
Deflating the first balloon after treating the first leaflet;
Inflating the second balloon with a liquid, the inflating the second balloon aligning the second balloon within a recess of only the second leaflet; and
19. The method of claim 18, further comprising: treating the second leaflet by applying a shock wave to the second leaflet by activating the second shockwave source.   The shock wave device is configured to prevent the balloon from interfering with blood flow to the coronary artery when the at least one balloon is inflated with liquid and is positioned with a concave portion of the leaflet. The method according to any one of claims 10 to 21, further comprising at least one standoff on at least one outer surface.   23. A method according to any one of claims 10 to 22, wherein advancing the shock wave device includes advancing the shock wave device in a retrograde direction.